Clinical Trials Directory

Trials / Unknown

UnknownNCT02260583

Effect of Extracorporeal CO2 Removal in Stable Hypercapnic COPD Patients

EFFECT OF EXTRACORPOREAL CO2 REMOVAL IN STABLE COPD PATIENTS WITH CHRONIC HYPERCAPNIC RESPIRATORY FAILURE:A PILOT STUDY

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
15 (estimated)
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

Summary

Chronic hypercapnic respiratory failure is common in stable COPD patients in a terminal phase of their disease In an attempt to correct or slow down the rate of rise of PaCO2, long-term noninvasive mechanical ventilation (NIV) has been proposed. Only very few studies demonstrated the clinical efficacy of NIV. Indeed this technique is not always well tolerated and therefore it may be effective only in a subset of patients The aim of this study is to assess the feasibility and safety of "one shot" extrcorporeal CO2 removal device, in reducing the PaCO2 level

Detailed description

Chronic hypercapnic respiratory failure is common in stable COPD patients in a terminal phase of their disease In an attempt to correct or slow down the rate of rise of PaCO2, long-term noninvasive mechanical ventilation (NIV) has been proposed. Only very few studies demonstrated the clinical efficacy of NIV. Indeed this technique is not always well tolerated and therefore it may be effective only in a subset of patients Recently extracorporeal CO2 removal have been shown to avoid the need of endotracheal intubation in COPD patients with an episode of Acute Hypercapnic Respiratory Failure In this pilot physiological study we want to assess the safety and efficacy of this technique in reducing the PaCO2 level in those COPD patients with chronic hypercapnic respiratory failure non responding to chronic NIV.

Conditions

Interventions

TypeNameDescription
DEVICEextracorporeal CO2 deviceAn ECCO2R device based on a modified continuous venovenous hemofiltration system will be used

Timeline

Start date
2014-10-01
Primary completion
2018-12-01
Completion
2018-12-01
First posted
2014-10-09
Last updated
2017-12-29

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT02260583. Inclusion in this directory is not an endorsement.